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Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development (TUMME)

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ClinicalTrials.gov Identifier: NCT00624689
Recruitment Status : Active, not recruiting
First Posted : February 27, 2008
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Niklas Timby, Umeå University

February 15, 2008
February 27, 2008
October 31, 2016
March 2008
March 2013   (Final data collection date for primary outcome measure)
Body composition [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT00624689 on ClinicalTrials.gov Archive Site
Neurological development [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development
Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development

Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity and cardiovascular diseases, neurological development and morbidity in infections.

The investigators' hypothesis is that a modified formula with reduced energy and protein content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins and phospholipids will reduce the difference between formula-fed and breast-fed infants.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Infant
Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)
MFGM-enriched formula with reduced energy and protein content
  • Experimental: 1
    Modified formula
    Intervention: Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)
  • No Intervention: 2
    Standard formula
  • No Intervention: 3
    Breastfed

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
Same as current
March 2018
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Term infants with birth weight 2500-4500 gr
  • Fed with breastmilk only or formula only before 2 months of age

Exclusion Criteria:

  • Chronic illness
Sexes Eligible for Study: All
up to 2 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00624689
TUMME
No
Not Provided
Not Provided
Niklas Timby, Umeå University
Umeå University
Not Provided
Not Provided
Umeå University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP